Wednesday, March 11, 2009

FDA Posts Said to be Filled--It's Hamburg and Sharfstein

According to the Wall Street Journal, president Barack Obama has decided on Dr. Margaret "Peggy" Hamburg as the next commissioner of the Food and Drug Administration, and Dr. Joshua Sharfstein as the next deputy FDA commissioner. No formal announcements have been made yet, but I assume that the WSJ has some pretty credible sources.

You can learn more about Dr. Hamburg from this interesting biography published by the National Library of Medicine. You can find out more about her extremely impressive credentials on the website of Henry Schein, a medical and dental equipment company where she serves on the Board of Directors. Hamburg is a public health maven, and has made a name for herself in designing a great tuberculosis control program in New York City and more recently in combating the threat of bioterrorism at the Nuclear Threat Initiative.

Joshua Sharfstein is currently head of the Baltimore Health Department, and is the son of Steve Sharfstein, a former progressive president of the American Psychiatric Association. You can read some background in a past WSJ blog posting here, where you can find links to a variety of interesting initiatives, such as his scrutiny of over-the-counter cold medicines for children. Like his father, Josh Sharfstein has a sharp eye out for drug industry improprieties--when he was a resident, he alerted the New England Journal of Medicine that Pfizer was inviting docs to a “rack ‘em up and toss ‘em down” event including billiards and lots of alcohol. He wrote that “attending such an event is unethical, according to the guidelines of the American Medical Association’s council on ethical and judicial affairs.”

From the Carlat perspective (honesty in medical education, putting patients ahead of profits), both of these appointments are excellent. I look forward to the next few years at the FDA!

8 comments:

therapyfirst
said...

Yeah, with the entrenched underlings sabotoging their efforts every step of the way! Just like in Congress: once they (the career reps and senators) get jealous with Obama getting alleged credit for efforts to improve this crumbling economy, they will turn on him like starving hyenas turn on their young. Pharma has their contacts at the FDA; the real question is will these two show some intestinal fortitude and can some asses who show no respect or concern for the public.

Time will tell.

By the way, thanks for canning that joker SC. 9 months too late to me.

re intestinal fortitude, see Sharfstein NEJM 1994. Josh has some serious stones. (But beware: NEJM, horror of horrors, includes abundant drug-company sponsored advertisements, as it did when Marcia and Bud were there.)

therapyfirst: Look at FDA's mandate, and their resources, and tell us what exactly these 'underlings' you disparage so readily could do differently. Be specific.

If my opinion is viewed as disparaging or demeaning, explain to me how so many medications in the past 10 years alone got FDA approval when these committees and advisory boards UNDER the FDA Director ok'd the go ahead. And I am not just focused on psych meds, but the fiascos with NSAIDs and diabetes meds that caused serious ramifications.

I am not willing to be nice or engage in respectful dialogue when you deal with entities that are solely focused on the bottom line: profits. If I am wrong, I will apologize and do it sincerely and responsibly. So far most of my comments have been supported by the facts and details courageously reported by those who care, that others who have much to lose, ie their money, then want to harass and demean the caring for being whistleblowers and responsible citizens.

I just have this to say to those who are industry apologists and defenders: I hope you all go down with this ship of fools and corrupted clinicians who left the Hippocratic Oath in the trashcan when they exited the auditorium following their medical school graduations.

You can't dialogue with evil, and that is what a good portion of pharma has fallen to these days.

And so few have the guts and intergrity to say so. Is my position a bit clearer now?

The FDA, which is charged to balance medical progress, safety, and ethics, has an awesome responsibility to both help facilitate the development of life-saving drugs and to protect the citizenry at the same time if those agents are harmful. This is a monumental task, steeped in both the realms of medicine and politics. Like anything political, it swings with the proverbial pendulum according to the market forces of the day. What alarms me is that the pendulum may be swinging against the development of psychoactive drugs.

Compared to the period between 1995-2005, the pharmaceutical pipelines of psychotropic drugs have been reduced dramatically. Have we hit a wall in scientific development that must be overcome before a "new generation" of psychiatric medications emerge, or has the field cried wolf one too many times, causing industry to move more R & D dollars to areas such as oncology, for example?

Doing the right thing has its consequences, as we teach our children, but is a necessary part of life-development. So, too, is trying to reduce perceived conflict of interest issues in medical marketing. Not an easy job, as this blog has well established. It is just too simplistic (and I submit counterproductive) to bad mouth the drug industry and justify all the broad-brush statements about the "evils of industry" on the Hippocratic Oath.

Physicians, Industry, and the FDA, make up the core of medicine's circulatory system. There is no getting around that. So I suggest that instead of tearing-down one part of this circulatory system, we try to find ways to make every part of the system strong. Blood flows best when it is unobstructed. If nothing else, one must remember the third of Sir Issac Newton's laws of physics, "Every Action has an Equal and Opposite Reaction." I, for one, want to see more psychotropic drug development -- not less. And that, ladies and gentlemen, is the bottom line. Best regards to all, j

While I respect your input on various topics, I have to ask outloud why you say "I for one want to see more psychotropic drug development..."

Why? With what we are learning these companies are fostering on an unsuspecting patient and physician population, I think it is more than fair to assume schenanigans until altruism is again the mainstay of the process.

Besides, as a physician, we were trained to go from least to most invasive, so if you are an advocate to the mental health process, why aren't you championing for more therapy access for psychiatrists?

I am all for transparency, TF. You and I are on the same page on this. And I am all for therapy -- but that is more of an insurance issue that has nothing to do w/ the pharma industry, CME, or the FDA, which are the matters in play here.

So. Why do I want to see more psychotropic development? Wouldn't we all want to see an antidepressant with immediate onset and no drug interactions? Or an antipsychotic devoid of the usual side effects and diabetes risk? How about an agent that stops the progression of Alzheimer's and doubles as an effective antiparkinsonian agent? What's the value in one less suicide, an intact family no longer splintered by domestic violence, or one fewer fatal car crash because the driver's meds helped him sleep properly? These things are without measure. Just look at the advances in psychiatry of the last 25 years? They have been remarkable. Why wouldn't we want the next 25 years to be as robust?

The pharmaceutical industry is plagued by the same market forces as any other business. We hold them to a higher standard because lives are at stake and, perhaps, that is justified. Nevertheless, it is in medicine's best interest that we have a healthy, thriving pharmaceutical industry. It is in medicine's best interest that the FDA be the gold standard regulatory body of the world. It is in medicine's best interest that physicians have as many tools at their disposal for patient's who may have budget constraints, quality of life issues, and/or comorbid illnesses, to name a few.

I don't know if "altruism" was ever the "mainstay of the process," as you write. But, the patent conflict of interest issues discussed at length on this blog can help get things back on track. My take is that CME accreditation -- as a measure of regulatory scrutiny -- has run its course. Take that out of the equation and stop vilifying industry and the FDA because of a (very) few greedy doctors who lost their way. It's time to solve the problem. Enough gas has been poured over these flames already. God knows you have the smarts, TF, to contribute to a satisfactory resolution. The question is, do you have the requisite common sense? Are we all too consumed with our private prejudices to turn things around? If so, perhaps you will get your wish after all and drug development in psychiatry will continue to slow.

Please excuse the grouchiness. My morning Cheerios don't have the efficacy they once did. I'd switch to Wheaties, but the Cheerios company just sent me a pen shaped like a bagel, so I can't. Italian/Jewish guilt -- the worst! Enjoy your weekend ... j

Again, I totally disagree with you, as psychiatry first allowed the insurance industry to tell us how to practice our profession from diagnosing to treatment. Pharma saw us as the sitting duck we became and suckered us into this lame ass "Decade of the Brain" BS of the 1990's and connived us into thinking we were just pharmacologists and, as someone so accurately put it, "hydraulic operators" in just raising and lowering drugs. Pharma then took over CME and tricked too many physicians into thinking that CMEs should be free and were able to direct the facts to pharma's own benefit. The FDA, gutted moreso in the past 8 years by an equally corrupt Republican majority (but don't let Democrats off easily 'cause now they are looking to cash in as the majority), looked the other way to allow pharma to set the tone for approvals and even try to neutralize punishments that deservedly should have been implemented.

I am going to say something that will piss you and other non-physician readers off, but it is a truth I believe too many physicians are just afraid to say and/or admit. YOU HAVE TO PRACTICE HEALTH CARE AS A DOCTOR OR OTHER FRONT LINE CLINICIAN TO REALLY APPRECIATE AND RESPECT WHAT IT MEANS TO CARE FOR PEOPLE. I am sick and tired of people who do not do the work I and my colleagues do day in and out, and come across like they are an equal and I have to give validation to such non-clinicians's perspectives.

Well, guess what? I don't second guess my mechanic when he shows me he is fixing my car, I don't second guess my plumber when he is locating a leak, and I don't second guess my accountant who is handling my taxes. So, to you Mr LaRossa and all the others who come across as knowing how I became a doctor and how I practice my profession now, invite me over to tell you how to do your job, and I am so sure you will be so receptive and accepting of my opinions and directions. NOT!!!

And guess what else? Altruism is part of the code of being a doctor. I am sorry my lame ass colleagues' recent examples blur that expectation from the public's and responsible physicians' recall.

You have to walk in my shoes a fair bit to be critical in the end. I recently wrote a critical email to a colleague, who wrote back "there is no room for criticism here." You know what I wrote back? "Criticism between colleagues is part of the job, sometimes it is unsubstantiated, and sometimes it ends up making us a better physician."

Comes back to what a supervisor in residency said that haunts me forever: "every one thinks they are a psychiatrist until they screw it up and leave us facing the fan alone." Unfortunately, too many psychiatrists have shown incredibly poor judgment to ruin it for what I hope is still a sizeable majority to take back this profession and regain respect.

A rant, but I had to say it! And now will come the rebuttals. Thank you for hopefully publishing this, Dr Carlat.

The very FIRST change I would like to see happen would be for government to separate the FDA into to seperate administrations, Food in one and Drugs in another. Next, I would like to see new studies NOT CONDUCTED BY THE FDA to be government supervised on artificial colors and flavors, faux sweeteners, and perseratives.All the additives are killing us and our children. Sadly it took until my daughter was 4 to uncover the truths on these things. For four years she was drugs and counceled and judged and labeled. Now that we eat additive free, she is calm and loving and sweet and fun and top of her class!FDA shmefda..... I would LOVE to see over due changes with this administration, but for some reason, Im not holding my breath....

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About Dr. Carlat

I am a psychiatrist in Newburyport, Massachusetts and an Associate Clinical Professor of Psychiatry at Tufts Medical School (but note that the opinions expressed in this blog are not those of Tufts). I graduated from the psychiatric residency at Massachusetts General Hospital in 1995, and am the founder and publisher of three CME newsletters, including The Carlat Psychiatry Report. In March 2012, I left the publishing world to work on conflict of interest issues for The Pew Charitable Trusts, as director of the Pew Prescription Project. I returned to Newburyport and Carlat Publishing in September 2014.